Trial Outcomes & Findings for 26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation (NCT NCT01827592)

NCT ID: NCT01827592

Last Updated: 2015-10-20

Results Overview

This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 376 participants
• Primary outcome timeframe: During the first 12 weeks
• Results posted on: 2015-10-20

Participant Flow

The trial included a 4-week Screening Period and a 2-week Pretreatment Period prior to patient randomization to a 26-week Treatment Period. A total of 909 patients were screened in the trial and of these 533 patients were excluded due to screening failure.

Participant milestones

Measure	EBX 10 Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.	EBX 5 Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Overall Study STARTED	126	126	124
Overall Study Safety Analysis Set	125	126	124
Overall Study COMPLETED	52	46	48
Overall Study NOT COMPLETED	74	80	76

Reasons for withdrawal

Measure	EBX 10 Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.	EBX 5 Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Overall Study Adverse Event	11	9	2
Overall Study Physician Decision	0	2	1
Overall Study Protocol Violation	2	1	0
Overall Study Lost to Follow-up	1	2	2
Overall Study Withdrawal by Subject	12	11	11
Overall Study Patient's substantial non-compliance	1	1	6
Overall Study Trial terminated by Sponsor	47	53	51
Overall Study Others	0	1	3

Baseline Characteristics

26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation

Baseline characteristics by cohort

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.	Total n=376 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants	113 Participants n=7 Participants	112 Participants n=5 Participants	335 Participants n=4 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	41 Participants n=4 Participants
Age, Continuous	48.0 Years STANDARD_DEVIATION 14.3 • n=5 Participants	45.8 Years STANDARD_DEVIATION 14.1 • n=7 Participants	46.1 Years STANDARD_DEVIATION 14.4 • n=5 Participants	46.6 Years STANDARD_DEVIATION 14.3 • n=4 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	107 Participants n=7 Participants	103 Participants n=5 Participants	314 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	62 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	32 Participants n=7 Participants	28 Participants n=5 Participants	86 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants	94 Participants n=7 Participants	96 Participants n=5 Participants	290 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	23 Participants n=7 Participants	29 Participants n=5 Participants	80 Participants n=4 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	97 Participants n=7 Participants	87 Participants n=5 Participants	279 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Canada	6 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	17 participants n=4 Participants
Region of Enrollment Czech Republic	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment Belgium	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment United States	73 participants n=5 Participants	78 participants n=7 Participants	77 participants n=5 Participants	228 participants n=4 Participants
Region of Enrollment Poland	2 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	31 participants n=4 Participants
Region of Enrollment South Africa	14 participants n=5 Participants	11 participants n=7 Participants	14 participants n=5 Participants	39 participants n=4 Participants
Region of Enrollment Germany	15 participants n=5 Participants	16 participants n=7 Participants	15 participants n=5 Participants	46 participants n=4 Participants
Weekly number of CSBM	0.36 CSBM per week STANDARD_DEVIATION 0.66 • n=5 Participants	0.44 CSBM per week STANDARD_DEVIATION 0.75 • n=7 Participants	0.54 CSBM per week STANDARD_DEVIATION 0.82 • n=5 Participants	0.45 CSBM per week STANDARD_DEVIATION 0.75 • n=4 Participants
Weekly number of SBM	2.20 SBM per week STANDARD_DEVIATION 1.34 • n=5 Participants	2.13 SBM per week STANDARD_DEVIATION 1.27 • n=7 Participants	2.31 SBM per week STANDARD_DEVIATION 1.43 • n=5 Participants	2.21 SBM per week STANDARD_DEVIATION 1.35 • n=4 Participants

PRIMARY outcome

Timeframe: During the first 12 weeks

Population: Intention-to-treat (ITT) analysis set consisted of all randomized (as planned) patients.

This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.

Outcome measures

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Overall Complete Spontaneous Bowel Movement (CSBM) Response	15.9 Percentage of patients	23.0 Percentage of patients	12.1 Percentage of patients

SECONDARY outcome

Timeframe: Within the first 24 hours of treatment initiation

Population: The ITT analysis set consisted of all randomized (as planned) patients was used for assessment.

This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').

Outcome measures

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Occurrence of CSBM Response	20.6 Percentage of patients	24.6 Percentage of patients	12.1 Percentage of patients

SECONDARY outcome

Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

Population: The ITT analysis set consisted of all randomized (as planned) patients.

The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.

Outcome measures

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)	2.04 SBM per week Interval 1.64 to 2.44	2.44 SBM per week Interval 2.04 to 2.84	1.55 SBM per week Interval 1.15 to 1.95

SECONDARY outcome

Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

Population: The ITT analysis set consisted of all randomized (as planned) patients.

The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.

Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .

For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

Outcome measures

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Change From Baseline in Weekly Stool Consistency of SBMs	1.41 Units on BSFS Interval 1.24 to 1.58	1.35 Units on BSFS Interval 1.18 to 1.52	0.83 Units on BSFS Interval 0.66 to 1.0

SECONDARY outcome

Timeframe: At 12 weeks

Population: The ITT analysis set consisted of all randomized (as planned) patients.

This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week of Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.

PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.

Total PAC-QOL score was averaged from the individual item score.

Outcome measures

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder	34.1 Percentage of patients	33.3 Percentage of patients	25.8 Percentage of patients

SECONDARY outcome

Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

Population: The ITT analysis set consisted of all randomized (as planned) patients.

The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).

For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

Outcome measures

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Change From Baseline in Weekly Degree of Straining of SBMs	-1.01 Units on a scale Interval -1.15 to -0.88	-1.04 Units on a scale Interval -1.17 to -0.91	-0.91 Units on a scale Interval -1.05 to -0.78

SECONDARY outcome

Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

Population: The ITT analysis set consisted of all randomized (as planned) patients.

The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).

For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

Outcome measures

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Change From Baseline in Weekly Abdominal Bloating Score	-0.49 Units on a scale Interval -0.61 to -0.38	-0.52 Units on a scale Interval -0.63 to -0.4	-0.35 Units on a scale Interval -0.47 to -0.24

SECONDARY outcome

Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

Population: The ITT analysis set consisted of all randomized (as planned) patients.

The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).

For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

Outcome measures

Measure	EBX 10 n=126 Participants Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 Participants Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 Participants Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Change From Baseline in Weekly Abdominal Discomfort Score	-0.43 Units on a scale Interval -0.54 to -0.32	-0.46 Units on a scale Interval -0.57 to -0.35	-0.38 Units on a scale Interval -0.49 to -0.27

Adverse Events

EBX 10

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

EBX 5

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

PLCBO

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	EBX 10 n=125 participants at risk Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 participants at risk Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 participants at risk Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Eye disorders Glaucoma	0.80% 1/125 • Number of events 1 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/126 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/124 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Gastrointestinal disorders Haemorrhoids	0.00% 0/125 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/126 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.81% 1/124 • Number of events 1 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Hepatobiliary disorders Cholecystitis	0.00% 0/125 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.79% 1/126 • Number of events 1 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/124 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Musculoskeletal and connective tissue disorders Back pain	0.80% 1/125 • Number of events 1 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/126 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/124 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/125 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.79% 1/126 • Number of events 1 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/124 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/125 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.79% 1/126 • Number of events 1 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/124 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.80% 1/125 • Number of events 1 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/126 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	0.00% 0/124 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.

Other adverse events

Measure	EBX 10 n=125 participants at risk Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	EBX 5 n=126 participants at risk Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.	PLCBO n=124 participants at risk Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
Gastrointestinal disorders Abdominal pain	14.4% 18/125 • Number of events 22 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	4.8% 6/126 • Number of events 6 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	5.6% 7/124 • Number of events 11 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Gastrointestinal disorders Diarrhoea	8.8% 11/125 • Number of events 21 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	7.1% 9/126 • Number of events 14 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	2.4% 3/124 • Number of events 4 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Infections and infestations Nasopharyngitis	8.0% 10/125 • Number of events 10 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	5.6% 7/126 • Number of events 7 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	8.9% 11/124 • Number of events 12 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Infections and infestations Urinary tract infection	5.6% 7/125 • Number of events 8 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	4.0% 5/126 • Number of events 6 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	2.4% 3/124 • Number of events 3 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
Nervous system disorders Headache	4.8% 6/125 • Number of events 7 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	5.6% 7/126 • Number of events 7 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.	4.0% 5/124 • Number of events 5 • 34 weeks The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: DK0-Disclosure@ferring.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
• Publication restrictions are in place

Restriction type: OTHER